^
    1d
    Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging (clinicaltrials.gov)
    P2, N=156, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HER-2 positive • HER-2 amplification
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    Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • albumin-bound paclitaxel
    1d
    Close2HER: A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Hoffmann-La Roche
    New trial • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive
    1d
    Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study. (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Hebei Medical University Fourth Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
    1d
    Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy (clinicaltrials.gov)
    P3, N=280, Not yet recruiting, Fudan University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Irene (pyrotinib)
    2d
    Genetic Testing in Guiding Treatment for Patients With Brain Metastases (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Alliance for Clinical Trials in Oncology | Suspended --> Active, not recruiting | N=186 --> 50
    Enrollment closed • Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    HER-2 positive • EGFR mutation • HER-2 negative • BRAF positive
    |
    Rozlytrek (entrectinib) • Verzenio (abemaciclib) • Krazati (adagrasib) • paxalisib (GDC-0084)
    2d
    Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment (HER2 CR) (clinicaltrials.gov)
    P=N/A, N=50, Active, not recruiting, Nagoya City University | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date • Circulating tumor DNA
    |
    Signatera™
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    2d
    A First-in-human, Clinical Trial Assessing the Safety of ES2B-C001-S01 With or Without [Adjuvant] in Patients With HER2-expressing Metastatic Breast Cancer. (clinicaltrials.gov)
    P1, N=40, Recruiting, ExpreS2ion Biotechnologies | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    ES2B-C001
    2d
    Radiomics Nomogram Based on Multiparametric MRI for Predicting the Hormone Receptor Status of HER2-Low Expression Breast Cancer. (PubMed, J Comput Assist Tomogr)
    An mpMRI-based nomogram incorporating radscore and clinical-radiological characteristics showed good predictive efficacy for assessing the HR status of HER2-low expression breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 expression • HER-2 underexpression
    2d
    Targeted Therapies for Each Subtype of Breast Cancer. (PubMed, MedComm (2020))
    This review comprehensively summarizes recent advances in targeted therapies for major BC subtypes: endocrine therapy combined with cyclin-dependent kinase 4/6 (CDK4/6) or phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) inhibitors for HR-positive BC; novel antibody‒drug conjugates (ADCs) such as trastuzumab deruxtecan (T-DXd) and tyrosine kinase inhibitors (TKIs) for HER2-positive BC; and trophoblast cell-surface antigen 2 (Trop-2) ADCs, immunotherapies, and poly-ADP-ribose polymerase (PARP) inhibitors for TNBC. It also discusses cross-subtype therapeutic platforms (ADCs, PI3K/AKT/mTOR pathway) and emerging modalities (chimeric antigen receptor [CAR] T-cell therapy, proteolysis-targeting chimeras [PROTACs]). By analyzing successes, challenges, and translational potential, this review provides a clear framework for clinicians and researchers, advancing personalized treatment optimization and addressing unmet clinical needs in BC precision oncology.
    Review • Journal • PARP Biomarker • IO biomarker
    |
    ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • HR positive • EGFR positive
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    2d
    Subtype-Stratified Consensus Gene Signatures: Bridging Tumor Cell Biology, Immune Microenvironment, and Clinical Prognosis in Breast Cancer. (PubMed, Int J Mol Sci)
    Independent validation in the Lancet2005 ER+ cohort confirmed that Luminal prognostic gene sets robustly stratified distant relapse-free survival. Collectively, these subtype-specific consensus signatures integrate tumor cell biology and tumor immune microenvironment features, offering robust prognostic tools with potential for future clinical translation.
    Journal • Gene Signature
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2d
    Immunohistochemical Expression of IDO and PD-L1 in Distinct Compartments of Breast Cancer Tissue: Correlation with Clinicopathological Features and Outcomes. (PubMed, Cancers (Basel))
    In our study, IDO expression on tumor cells was predominantly observed in TNBC and was found to correlate with PD-L1 expression in the lymphocytic and stromal compartments. Furthermore, expression of PD-L1 among lymphocytes was found to independently correlate with unfavorable clinicopathological parameters, including high proliferation rate and negative hormone receptor status.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • IDO1 (Indoleamine 2,3-dioxygenase 1)
    |
    PD-L1 expression • HER-2 positive • ER negative